What Opcenter Execution Pharma is
It is a dedicated pharmaceutical MES. It guides operators through the approved recipe and process steps one at a time, and records every value that actually occurs into an electronic batch record, from raw material weighing through to batch release.
01
What it does
Enforces the recipe and SOP step by step, and writes values, timestamps and operator identity into the eBR automatically.
02
Where it sits
Between the ERP and the floor — scales, DCS, PLCs and barcode readers.
03
What you get
Bridge the gap between ERP, PLM, and Distributed Control Systems (DCS) for continuous compliance.
Why Choose Opcenter
Paperless Manufacturing
Eliminate human error and transcription risks with fully guided electronic workflows.
Review by Exception
Accelerate batch release cycles by focusing quality reviews only on deviations and exceptions.
Seamless Automation Integration
Bridge the gap between ERP, PLM, and Distributed Control Systems (DCS) for continuous compliance.
Built on the regulations from the start
21 CFR Part 11
Electronic signatures
Electronic records and signatures carry the same weight as paper, with an audit trail that cannot be altered.
EU Annex 11
Computerised systems
Meets the European requirements for computerised systems, covering validation and access control.
ALCOA+
Data integrity
Attributable, legible, contemporaneous, original and accurate – every record, every time.
GMP / SOP
Floor-level control
Blocks equipment that has not been cleaned or calibrated from
being used in production.
Five core capabilities
Electronic batch record (eBR)
- Track the operating state, cleaning status and calibration history of each machine
- Block equipment that is unsterilised or out of calibration from being used
- Enforce SOPs and GMP on the floor itself, not just in a binder
Review by exception
- The system catches deviations and alerts quality the moment they happen
- Reviewers look only at what fell outside specification, instead of reading the whole record
- Cuts the gap between the end of production and release from days to hours
Native automation integration
- Pull values from scales, DCS and PLCs straight into the record, with no manual entry
- Bring equipment status and process parameters across at the same time
- Close the gap where records drift most — copying a number off a screen onto paper
Weighing and dispensing
- Guide the operator through weighing and dispensing one step at a time
- Check material code, lot number and expiry date before allowing a weighing
- Confirm the scale is calibrated and within a suitable range
- Prevent the wrong material being picked and prevent cross-contamination
Equipment and cleanrooms
- Track the operating state, cleaning status and calibration history of each machine
- Block equipment that is unsterilised or out of calibration from being used
- Enforce SOPs and GMP on the floor itself, not just in a binder
How this differs from a paper batch record
The whole record gets read
QA goes through every page, even though most of it is uneventful.
Deviations show up at the end
A value out of range is found only after the batch is finished.
Handwriting is unclear
Someone has to track down whoever wrote it to confirm the number.
Values copied off a screen
The single most common place for a record to go wrong.
Release is slow
Review takes days for every batch.
A week of audit preparation
Files have to be dug out and sorted before the auditor arrives.
Only the deviations get read
The system has already picked out what needs attention.
You know the moment it drifts
The alert comes at that step, while the batch can still be saved.
Every value is legible
Along with who recorded it and exactly when.
Values arrive on their own
Taken from the scale and the DCS without passing through a person.
Release is quick
Review drops from days to hours.
Audit-ready at any time
Search a batch number and the whole history is there.
Pharmaceutical production under system control
Every cleanroom step is recorded with the operator who performed it and when.
Equipment values go straight into the batch record, with no manual entry.
Advance Your Pharmaceutical Manufacturing Today
Overcome the bottlenecks of traditional paper batch records and embrace digital compliance. Boost efficiency, ensure flawless quality, and accelerate your life sciences operations with Siemens Opcenter.
